In 2000 the Mutual Recognition Agreement (MRA) between Canada and Switzerland on Medicinal Products Drug GMP Compliance Certification (Sectoral Annex on GMP) became operational.
As of January 31, 2025, Health Canada and Swissmedic agreed to expand the existing approach to include both the recognition of GMP extra-jurisdictional inspection outcomes as well as active pharmaceutical ingredient and stable medicinal products derived from human blood or human plasma in the operational scope. Furthermore, they agreed on the information sharing and reliance processes related to Health Canada’s on-site evaluation and Swissmedic’s pre-approval inspection.
At present, the text of the MRA has not been revised as these changes were possible on the basis of the existing MRA. However, Swissmedic and Health Canada confirm their commitment to a revision of the MRA in due course to bring it more in line with the developments of the last 25 years.